DailyMed - DailyMed Details

SPL v3

SPL

SPL Set ID 55c0f077-e365-1d95-e054-00144ff8d46c

Route

TOPICAL

Published

Effective Date 2017-07-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (3.2 g)

Inactive Ingredients

Sodium Citrate Polihexanide Hydrochloride Propylene Glycol Decyl Glucoside Allantoin Water Glycerin Chlorphenesin Bronopol Polysorbate 20

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2017-07-29

Description

Dimethicone 3.2%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Dimethicone 3.2%

Use

provides temporary relief to irritated skin

Section 50565-1

Keep out of reach of children ,seek medical attention if swallowed

Section 51945-4

Warning

For external use only

Do not use on

Large cuts or wounds

severe burns

eyes or near mouth

stop use and call a doctor if

symptoms last for greater than 7 days or reoccur after clearing up

Directions

peel back sticker

clean affected area with wipe

dispose of wipe properly

reseal label

Active Ingredient

Dimethicone 3.2%

Inactive Ingredient

Aqua

Glycerin

Propylene Glycol

Polyaminopropyl Biguanide

Polysorbate 20

Allantoin

Chlorphenesin

Decyl Glucoside

2-Bromo-2-Nitropropane-1,3-Diol

Sodium Citrate

Structured Label Content

Use

provides temporary relief to irritated skin

Section 50565-1 (50565-1)

Keep out of reach of children ,seek medical attention if swallowed

Section 51945-4 (51945-4)

Purpose

Skin Protectant

Warning

For external use only

Do not use on

Large cuts or wounds

severe burns

eyes or near mouth

stop use and call a doctor if

symptoms last for greater than 7 days or reoccur after clearing up

Directions

peel back sticker

clean affected area with wipe

dispose of wipe properly

reseal label

Active Ingredient

Dimethicone 3.2%

Inactive Ingredient (INACTIVE INGREDIENT)

Aqua

Glycerin

Propylene Glycol

Polyaminopropyl Biguanide

Polysorbate 20

Allantoin

Chlorphenesin

Decyl Glucoside

2-Bromo-2-Nitropropane-1,3-Diol

Sodium Citrate

Advanced Ingredient Data

[{"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLIHEXANIDE HYDROCHLORIDE", "unii": "4XI6112496", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DECYL GLUCOSIDE", "unii": "Z17H97EA6Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLORPHENESIN", "unii": "I670DAL4SZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "3.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "BRONOPOL", "unii": "6PU1E16C9W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "provides temporary relief to irritated skin", "50565-1": "Keep out of reach of children ,seek medical attention if swallowed", "Purpose": "Skin Protectant", "Warning": "For external use only Do not use on Large cuts or wounds severe burns eyes or near mouth stop use and call a doctor if symptoms last for greater than 7 days or reoccur after clearing up", "Directions": "peel back sticker clean affected area with wipe dispose of wipe properly reseal label", "Active Ingredient": "Dimethicone 3.2%", "INACTIVE INGREDIENT": "Aqua Glycerin Propylene Glycol Polyaminopropyl Biguanide Polysorbate 20 Allantoin Chlorphenesin Decyl Glucoside 2-Bromo-2-Nitropropane-1,3-Diol Sodium Citrate"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:29.163469 · Updated: 2026-03-14T22:54:59.525683